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Table 5 Intervention arm – ‘poor response’ to chemoradiotherapy

From: A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial

Intervention arm – poor responders Registration period Intervention phase Annual follow-up Disease statusg
Visit type Prior to patient entry Registration Randomisation (baseline) Post CRT MDT Chemo-therapy for 12 weeks MDT surgery Surgical follow-up Adjuvant chemotherapy for 12 weeks 12 24 36 60
Timelines   ≤4 weeks prior to CRT During CRT 4–6 weeks post CRT   ≤12 weeks post CRT. Toxicity assessed at end of each cycle   6–12 weeks after pre-op chemo 6 weeks post surgery Toxicity assessed at end of each cycle during chemotherapy Months from end of CRT
Informed consenta   X X          
Check eligibility criteria   X X          
Diagnosis and clinical assessment   X           
Randomisation    X          
Quality of life   X        X   X  
Chemoradiotherapy    X          
Blood sampleb   X   X X   X   X X X  
Baseline MRI X            
Restaging MRIc     X X i        
Surgery       X       
Surgical morbidityf        X   X    
Pathologyd        X      
Chemotherapyh      X end of each cycle    X end of each cycle     
Toxicity assessment      X end of each cycle    X end of each cycle X    
Annual follow-upg          X X X X
Adverse eventse     X   X end of each cycle    X end of each cycle     
Concurrent medications   X X X   X end of each cycle X X X end of each cycle X    
  1. CRT preoperative chemoradiotherapy, MDT multidisciplinary team, MRI magnetic resonance imaging
  2. The X also denotes that Clinical Report Forms (CRFs) need completing – tick or initial the boxes as the CRFs are completed
  3. aEligible subjects will be asked to provide written informed consent at registration and before randomisation
  4. bIf patient has consented to additional blood sample collection for research
  5. cThe post-CRT MRI should to be performed within 4–6 weeks (maximum of 10 weeks) from completion of CRT
  6. dResected specimen will be prepared and evaluated using a standardised protocol
  7. eAll adverse events will be recorded from the date the post-CRT MRI scan is performed until 30 days after the last dose of chemotherapy is administered during the intervention phase of the trial
  8. fBoth early (4–6 weeks) and late surgical complications (at 12 months) will be recorded
  9. gDisease status at 5 years (does not require clinic visit): alive without metastatic or recurrent disease, alive with metastatic and/or recurrent disease (date diagnosed), dead (date of death)
  10. hChemotherapy toxicity is assessed every 6 weeks during chemotherapy treatment. 12 weeks (6 cycles of FOLFOX or 4 cycles of CAPOX) are given pre-operatively and 12 weeks (6 cycles of FOLFOX or 4 cycles of CAPOX) are given post-operatively
  11. iFurther MRI scan should be performed within 4–6 weeks from completion of pre-operative chemotherapy and mrTRG reported